U.S. patent number 10,828,011 [Application Number 14/916,056] was granted by the patent office on 2020-11-10 for devices and methods for determination of electrical dipole densities on a cardiac surface.
This patent grant is currently assigned to ACUTUS MEDICAL, INC.. The grantee listed for this patent is Acutus Medical, Inc.. Invention is credited to Graydon E. Beatty, J. Christopher Flaherty, Christoph Scharf, Gunter Scharf, Randell L. Werneth.
United States Patent |
10,828,011 |
Werneth , et al. |
November 10, 2020 |
Devices and methods for determination of electrical dipole
densities on a cardiac surface
Abstract
Disclosed are devices, systems, and methods for determining the
dipole densities on a cardiac surface using electrodes positioned
on a torso of a patient. Electrodes are integrated into a piece of
clothing worn by a patient. The clothing serves to fix the position
of the electrodes adjacent a patient's torso. Ultrasonic
transducers and sensors are used to determine a distance between
the epicardial surface and the electrodes and are also used to
detect epicardial surface motion as well as epicardial wall
thickness.
Inventors: |
Werneth; Randell L. (Boise,
ID), Beatty; Graydon E. (Bloomington, MN), Scharf;
Christoph (Horgen, CH), Scharf; Gunter (Zurich,
CH), Flaherty; J. Christopher (Auburndale, FL) |
Applicant: |
Name |
City |
State |
Country |
Type |
Acutus Medical, Inc. |
Carlsbad |
CA |
US |
|
|
Assignee: |
ACUTUS MEDICAL, INC. (Carlsbad,
CA)
|
Family
ID: |
52666502 |
Appl.
No.: |
14/916,056 |
Filed: |
September 10, 2014 |
PCT
Filed: |
September 10, 2014 |
PCT No.: |
PCT/US2014/054942 |
371(c)(1),(2),(4) Date: |
March 02, 2016 |
PCT
Pub. No.: |
WO2015/038607 |
PCT
Pub. Date: |
March 19, 2015 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20160192902 A1 |
Jul 7, 2016 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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61877617 |
Sep 13, 2013 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
18/02 (20130101); A61B 8/12 (20130101); A61B
18/1492 (20130101); A61B 5/04012 (20130101); A61B
6/032 (20130101); A61B 5/044 (20130101); A61B
5/0478 (20130101); A61B 5/4836 (20130101); A61B
18/20 (20130101); A61B 5/0036 (20180801); A61B
8/565 (20130101); A61B 3/113 (20130101); A61B
5/0432 (20130101); A61B 5/0452 (20130101); A61B
8/0883 (20130101); A61B 5/0205 (20130101); A61B
5/1072 (20130101); A61B 5/6805 (20130101); A61B
18/1815 (20130101); A61B 8/464 (20130101); A61B
5/0422 (20130101); A61B 8/4416 (20130101); A61B
5/04085 (20130101); A61B 2018/00994 (20130101); A61B
2576/023 (20130101); G16H 30/40 (20180101); A61B
2562/046 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61B 5/0408 (20060101); A61B
5/107 (20060101); A61B 3/113 (20060101); A61B
5/0205 (20060101); A61B 5/04 (20060101); A61B
5/042 (20060101); A61B 5/0432 (20060101); A61B
5/044 (20060101); A61B 5/0478 (20060101); A61B
6/03 (20060101); A61B 8/12 (20060101); A61B
18/02 (20060101); A61B 18/14 (20060101); A61B
18/18 (20060101); A61B 18/20 (20060101); A61B
5/0452 (20060101); A61B 8/00 (20060101); A61B
8/08 (20060101); A61B 18/00 (20060101) |
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Primary Examiner: Firchild; Mallika D
Assistant Examiner: Baldwin; Nathan A
Attorney, Agent or Firm: Onello & Mello, LLP
Parent Case Text
RELATED APPLICATIONS
The present application claims priority under 35 USC 119(e) to U.S.
Provisional Patent Application Ser. No. 61/877,617, entitled
"Devices and Methods for Determination of Electrical Dipole
Densities on a Cardiac Surface," filed Sep. 13, 2013, which is
incorporated herein by reference in its entirety.
The present application, while not claiming priority to, may be
related to U.S. patent application Ser. No. 13/858,715, entitled
"Method and Device for Determining and Presenting Surface Charge
and Dipole Densities on Cardiac Walls", filed Apr. 8, 2013, which
is a continuation of U.S. Pat. No. 8,417,313 (hereinafter the '313
patent), entitled "Method and Device for Determining and Presenting
Surface Charge and Dipole Densities on Cardiac Walls", issued Apr.
9, 2013, which was a 35 USC 371 national stage filing of PCT
Application No. CH2007/000380, entitled "Method and Device for
Determining and Presenting Surface Charge and Dipole Densities on
Cardiac Walls", filed Aug. 3, 2007, published as WO 2008/014629,
which claimed priority to Swiss Patent Application No. 1251/06
filed Aug. 3, 2006, each of which is hereby incorporated by
reference.
The present application, while not claiming priority to, may be
related to U.S. patent application Ser. No. 13/946,712, entitled
"Device and Method for the Geometric Determination of Electrical
Dipole Densities on the Cardiac Wall", filed Jul. 19, 2013, which
is a continuation of U.S. Pat. No. 8,512,255, entitled "Device and
Method for the Geometric Determination of Electrical Dipole
Densities on the Cardiac Wall", issued Aug. 20, 2013, published as
US2010/0298690 (hereinafter the '690 publication), which was a 35
USC 371 national stage application of Patent Cooperation Treaty
Application No. PCT/IB09/00071 filed Jan. 16, 2009, entitled "A
Device and Method for the Geometric Determination of Electrical
Dipole Densities on the Cardiac Wall", published as WO2009/090547,
which claimed priority to Swiss Patent Application 00068/08 filed
Jan. 17, 2008, each of which is hereby incorporated by
reference.
The present application, while not claiming priority to, may be
related to U.S. application Ser. No. 14/003,671, entitled "Device
and Method for the Geometric Determination of Electrical Dipole
Densities on the Cardiac Wall", filed Sep. 6, 2013, which is a 35
USC 371 national stage filing of Patent Cooperation Treaty
Application No. PCT/US2012/028593, entitled "Device and Method for
the Geometric Determination of Electrical Dipole Densities on the
Cardiac Wall", published as WO2012/122517 (hereinafter the '517
publication), which claimed priority to U.S. Patent Provisional
Application Ser. No. 61/451,357, each of which is hereby
incorporated by reference.
The present application, while not claiming priority to, may be
related to Patent Cooperation Treaty Application No.
PCT/US2013/057579, entitled "Catheter System and Methods of Medical
Uses of Same, Including Diagnostic and Treatment Uses for the
Heart", filed Aug. 30, 2013, which claims priority to U.S. Patent
Provisional Application Ser. No. 61/695,535, entitled "System and
Method for Diagnosing and Treating Heart Tissue", filed Aug. 31,
2012, which is hereby incorporated by reference.
The present application, while not claiming priority to, may be
related to U.S. Patent Provisional Application Ser. No. 61/762,363,
entitled "Expandable Catheter Assembly with Flexible Printed
Circuit Board (PCB) Electrical Pathways", filed Feb. 8, 2013, which
is hereby incorporated by reference.
Claims
We claim:
1. A device that generates a table of dipole density data that
embody an ionic nature of cellular membranes across the epicardium
of a patient's heart, comprising: a measuring and recording unit
that measures and records electric potential data V.sub.e at given
positions P, comprising: one or more ultrasound transducers
configured to be positioned proximate the patient's torso surface,
the one or more ultrasound transducers being configured to emit
ultrasound waves toward an epicardial surface of the patient's
heart; one or more ultrasound sensors configured to be positioned
proximate the patients torso surface, the one or more ultrasound
sensors being configured to receive reflections of the ultrasound
waves from the epicardial surface and to produce sensor data
related to the reflected ultrasound waves; an array of multiple
electrodes configured to be positioned proximate the patient's
torso surface; at least one probe electrode configured to be
positioned within a chamber of the patient's heart; and a flexible
wearable garment comprising a plurality of electrodes from the
multiple electrodes, at least one of the one or more ultrasound
transducers, and at least one of the one or more ultrasound
sensors, wherein the plurality of electrodes is fixedly mounted
within or on the wearable garment such that distances between
fixedly mounted electrodes are known separation distances; an
a/d-converter that converts the electric potential data V.sub.e
into digital voltage data; a processor configured to transform
cardiac surface geometry information from the sensor data related
to the reflected ultrasound waves and the digital voltage data into
dipole density data; and a memory that stores the electric
potential data V.sub.e and the dipole density data, wherein the
processor is configured to: record electric signals between
electrodes having the known separation distances from the plurality
of electrodes to determine calibrated signals values and to
determine distances between electrodes for which separation
distance is not known based on the electrical signals and the
calibrated signal values, the known distance and/or determined
distances between electrodes employed to compute the dipole density
data at vertices of polygonal shaped projections onto the
epicardial surface; use the sensor data related to the reflected
ultrasound waves to determine real-time continuous anatomical
geometry information of the chamber and to determine real-time
continuous measurements of the position of at least one of the
electrodes, at least one of the ultrasound transducers, and/or at
least one of the ultrasound sensors; and enhance the dipole density
data using at least one of the real-time continuous anatomical
geometry information or real-time continuous measurements of the
position.
2. The device of claim 1, wherein the wearable garment is flexible
and configured to conform closely to the patient's torso
surface.
3. The device of claim 1, wherein the wearable garment is
configured to urge at least one of the plurality of electrodes, the
at least one of the one or more ultrasound transducers, and/or the
at least one of the one or more ultrasound sensors of the wearable
garment against the patient's torso surface with a consistent
position to prevent movement.
4. The device of claim 1, wherein the processor includes a computer
program embodying an algorithm that, when executed by a processor,
transforms the digital voltage data into dipole density data.
5. The device of claim 1, wherein the processor is configured to
receive the sensor data from the one or more sensors and generate
distance measurements from the epicardial surface.
6. The device of claim 5, wherein the processor is configured to
produce the distance measurements by analyzing at least one of:
timing of received signal; recorded signal amplitude; sensor
recorded angle; or signal frequency changes.
7. The device of claim 1, wherein the wearable garment is selected
from the group consisting of: a vest; a shirt; a bib; an arm band;
a torso band; any patient-attachable assembly capable of
maintaining the at least one of the multiple electrodes, the at
least one of the one or more ultrasound transducers, and/or the at
least one of the one or more ultrasound sensors of the wearable
garment in contact with the torso surface, or sufficiently close
thereto that a monitorable signal is detectable; and/or
combinations thereof.
8. The device of claim 1, wherein the device is configured to
diagnose at least one of: an arrhythmia; ischemia; or compromised
myocardial function.
9. The device of claim 1, wherein the device is configured to treat
at least one of: an arrhythmia; ischemia; or compromised myocardial
function.
10. A device for creating a database of dipole densities d(y) and
distance measurements at an epicardial surface of a patient's
heart, the device comprising: an array of multiple electrodes
configured to be positioned proximate the patients torso surface
and a probe electrode configured to be positioned within a chamber
of the patient's heart; one or more ultrasound transducers
configured to be positioned proximate the patient's torso surface,
the one or more ultrasound transducers being configured to emit
ultrasound waves toward the epicardial surface; one or more
ultrasound sensors configured to be positioned proximate the
patients torso surface, the one or more ultrasound sensors being
configured to receive reflections of the ultrasound waves from the
epicardial surface; a wearable garment comprising a plurality of
electrodes from the multiple electrodes, at least one of the one or
more ultrasound transducers, and at least one of the one or more
ultrasound sensors, wherein distances between electrodes of the
wearable garment are known separation distances; and a computer
coupled to the multiple electrodes, the one or more ultrasound
transducers, and the one or more ultrasound sensors, wherein the
computer is configured to: record electric signals between
electrodes having the known separation distances of the wearable
garment to determine calibrated signals values and to determine
distance measurements between the electrodes for which separation
distance is not known based on the electrical signals and the
calibrated signal values, and receive mapping information from the
multiple electrodes and sensor data from the one or more ultrasound
sensors, the sensor data providing cardiac surface geometry
information, use the sensor data to determine real-time continuous
anatomical geometry information of the chamber and to determine
real-time continuous measurements of the position of at least one
of the electrodes, at least one of the ultrasound transducers,
and/or at least one of the ultrasound sensors; and generate the
database of dipole densities d(y) from the distance measurements,
the mapping information, and the cardiac surface geometry
information, wherein the distance measurements include at least one
of the known distances, the determined distances, or real-time
continuous measurements of the position, and wherein the cardiac
surface geometry includes the real-time continuous anatomical
geometry information.
11. The device of claim 10, wherein the wearable garment is
flexible and configured to conform closely to the patient's torso
surface.
12. The device of claim 10, wherein the wearable garment is
flexible and configured to urge at least one of the plurality of
electrodes, the at least one of the one or more ultrasound sensors,
and/or the at least one of the one or more ultrasound transducers
of the wearable garment against the patient's torso surface with a
consistent position to prevent movement.
13. The device of claim 10, wherein the wearable garment is
selected from the group consisting of: vest; shirt; bib; arm band;
torso band; any patient-attachable assembly capable of maintaining
the at least one of the multiple electrodes, the at least one of
the one or more ultrasound transducers, and/or the at least one of
the one or more ultrasound sensors of the wearable garment in
contact with the torso surface, or sufficiently close thereto that
a monitorable signal is detectable; and/or combinations
thereof.
14. The device of claim 10, wherein the computer is coupled to the
wearable garment.
15. The device of claim 10, wherein the computer includes: a dipole
density module configured to generate a three dimensional database
of dipole densities d(y), wherein the dipole density module is
configured to determine a dipole density for polygonal shaped
projections onto the epicardial surface and compute the dipole
density at all vertices of the polygonal shaped projections.
16. The device of claim 15, wherein the dipole density module
generates the database of dipole densities d(y) using a finite
elements method.
17. The device of claim 15, wherein the polygonal shaped
projections are substantially the same size.
18. The device of claim 15, wherein the dipole density is
determined by a number of polygonal shaped projections, the number
determined by the size of an epicardial surface.
19. The device of claim 10, wherein the device is configured to
provide epicardial surface motion information of the heart.
20. The device of claim 19, wherein the device is configured to
provide tissue diagnostic information by analysing both motion
information and cell electrical signals.
21. The device of claim 20, wherein the cell electrical signals are
recorded by the multiple electrodes.
22. The device of claim 10, wherein the device further includes a
display coupled to the computer and configured to display real time
motion.
23. The device of claim 10, wherein the computer is configured to
produce a geometrical depiction of the heart.
24. The device of claim 10, wherein the device is further
configured to determine properties of the cardiac wall.
25. The device of claim 24, wherein the properties include cardiac
wall thickness information.
26. The device of claim 24, wherein the properties include precise
foci, conduction-gaps, and/or conduction channels position
information.
27. The device of claim 10, wherein the distance measurement
comprises the distance between at least one of the multiple
electrodes and at least one epicardial surface.
28. The device of claim 27, wherein the device is configured to
produce the distance measurement by analyzing at least one of:
timing of received signal; recorded signal amplitude; sensor
recorded angle; or signal frequency changes.
29. The device of claim 10, wherein the device is configured to
provide epicardial surface information during a cardiac ablation
procedure.
30. The device of claim 29, wherein the ablation procedure
comprises delivery of RF, ultrasound, microwave, cryogenic and/or
laser energy to tissue.
31. The device of claim 10, wherein at least one of the sensors and
at least one of the transducers comprises a single component.
32. The device of claim 10, wherein the computer is configured to
determine a map of dipole densities d(y) at corresponding time
intervals.
33. The device of claim 10, wherein the computer is configured to
generate a synthesis of maps that represents a cascade of
activation sequences of each corresponding heart beat from a series
of heart beats.
34. The device of claim 10, wherein the device is configured to
diagnose at least one of: an arrhythmia; ischemia; or compromised
myocardial function.
35. The device of claim 10, wherein the device is configured to
treat at least one of: an arrhythmia; ischemia; or compromised
myocardial function.
36. A method of processing cardiac activity of a patient, said
method comprising: placing an array of multiple electrodes, one or
more ultrasound transducers, and one or more ultrasound sensors
proximate the patients torso surface, including: providing a
wearable garment comprising a plurality of electrodes from the
multiple electrodes, at least one of the one or more ultrasound
transducers, and at least one of the one or more ultrasound
sensors, wherein distances between electrodes of the wearable
garment are known separation distances; calculating dipole
densities d(y) by: recording electric signals between electrodes of
the wearable garment having known separation distances and
determining therefrom calibrated signal values, and calculating
distance information, including determining distances between
electrodes for which separation distance is not known based on the
electrical signals and the calibrated signal values; receiving
mapping information from the multiple electrodes; emitting waves
toward the epicardial surface with the one or more ultrasound
transducers; receiving reflections of the waves from the epicardial
surface with the one or more ultrasound sensors to produce sensor
data; producing a geometrical depiction of the epicardial surface
from the sensor data, including using the sensor data to determine
real-time continuous anatomical geometry information of the
chamber; using the sensor data to determine real-time continuous
measurements of the position of at least one of the electrodes, at
least one of the ultrasound transducers, and/or at least one of the
ultrasound sensors; receiving mapping information from at least one
probe electrode positioned within a chamber of the patient's heart;
and generating a database of dipole densities d(y) with a dipole
density module, wherein the dipole density module determines dipole
densities d(y) of polygonal shaped projections onto the geometrical
depiction of the epicardial surface, wherein the dipole density
module computes the dipole density at all vertices of the polygonal
shaped projections from the mapping information and the distance
information; and calculating distances to the epicardial surface or
movement of the epicardial surface by analysing signals received
from the one or more ultrasound sensors.
37. The method of claim 36, wherein the dipole density module
generates the database of dipole densities d(y) using a finite
elements method.
38. The method of claim 36, wherein the wearable garment is
configured to urge the at least one of the multiple electrodes, the
at least one of the one or more ultrasound sensors and/or the at
least one of the one or more ultrasound transducers of the wearable
garment against the torso surface with a consistent position to
prevent movement.
39. The method of claim 36, wherein the wearable garment is
selected from the group consisting of: vest; shirt; bib; arm band;
torso band; any patient-attachable assembly capable of maintaining
the at least one of the multiple electrodes in contact with the
torso surface or sufficiently close thereto that a monitorable
signal is detectable; and/or combinations thereof.
40. The method of claim 36, wherein calculating the distances to
the epicardial surface further comprises calculating tissue
thickness information.
41. The method of claim 36, including using the dipole densities
d(y) to locate an origin of abnormal electrical activity of a
heart.
42. The method of claim 36, including using the dipole densities
d(y) to diagnose at least one of: an arrhythmia; ischemia; or
compromised myocardial function.
43. The method of claim 36, including using the dipole densities
d(y) to treat at least one of: an arrhythmia; ischemia; or
compromised myocardial function.
44. The method of claim 36, wherein calculating the dipole
densities d(y) includes a processor executing a computer program
stored in a memory, the computer program embodying an algorithm for
generating a table of dipole densities in the memory.
45. The method of claim 36, wherein at least one ultrasound
transducer comprises at least one ultrasound sensor.
Description
FIELD
The present invention is generally related to treatment of cardiac
arrhythmias, and more particularly to devices and methods for
dipole density mapping.
BACKGROUND
For localizing the origin(s) of cardiac arrhythmias it is common
practice to measure the electric potentials located on the inner
surface of the heart by electrophysiological means within the
patient's heart. One method is to insert electrode catheters into
the heart to record cardiac potentials during normal heart rhythm
or cardiac arrhythmia. If the arrhythmia has a regular activation
sequence, the timing of the electric activation measured in
voltages at the site of the electrode can be accumulated when
moving the electrode around during the arrhythmia, to create a
three-dimensional map of the electric activation. By doing this,
information on the localization of the source of arrhythmia(s) and
mechanisms, i.e., re-entry circuits, can be diagnosed to initiate
or guide treatment (radiofrequency ablation). The information can
also be used to guide the treatment of cardiac resynchronization,
in which implantable pacing electrodes are placed in specific
locations within the heart wall or chambers to re-establish a
normal level of coordinated activation of the heart.
A method using external sensors measures the electrical activity of
the heart from the body surface using electrocardiographic
techniques that include, for example, electrocardiograms (ECG) and
vectorcardiography (VCG). These external sensor techniques can be
limited in their ability to provide information and/or data on
regional electrocardiac activity. These methods can also fail to
localize bioelectric events in the heart.
A method using external sensors for the localization of cardiac
arrhythmias utilizes body surface mapping. In this technique,
multiple electrodes are attached to the entire surface of the
thorax and the information of the cardiac electrograms (surface
ECG) is measured in voltages that are accumulated into maps of
cardiac activation. This measurement can be problematic because the
electrical activity is time dependent and spatially distributed
throughout the myocardium and also fails to localize bioelectric
events in the heart. Complex mathematical methods are required to
determine the electric activation upon the outer surface of a heart
model (i.e. epicardium), for instance, one obtained from CT or MRI
imaging giving information on cardiac size and orientation within
the thoracic cavity.
Alternatively, recordings of potentials at locations on the torso,
for example, can provide body surface potential maps (BSPMs) over
the torso surface. Although the BSPMs can indicate regional cardiac
electrical activity in a manner that can be different from
conventional ECG techniques, these BSPM techniques generally
provide a comparatively low resolution, smoothed projection of
cardiac electrical activity that does not facilitate visual
detection or identification of cardiac event locations (e.g., sites
of initiation of cardiac arrhythmias) and details of regional
activity (e.g., number and location of arrythmogenic foci in the
heart).
Since the localization of cardiac arrhythmias by the use of
potentials is imprecise, the successful treatment of cardiac
arrhythmias has been difficult and has demonstrated limited success
and reliability. There is, therefore, a need for improved methods
of localizing cardiac arrhythmias.
SUMMARY
In accordance with aspects of the present invention, provided are
devices and methods for dipole density mapping, as well as methods
for diagnosing tissue health. The present invention includes one or
more electrodes configured to record electrical activity of tissue.
In some embodiments, one or more ultrasound transducers, ultrasound
sensors, and/or combinations of these can be included. The
electrodes, transducers and sensors are located proximate the torso
surface, and can be coupled to a wearable garment, such as a vest,
shirt or bib. The device is constructed and arranged to produce
continuous, real-time geometries of a patient's tissue, as well as
information related to electrical activity present in the
tissue.
The device can also be capable of providing tissue information, for
example, tissue movement and tissue thickness. Additionally, the
device can be configured to produce distance measurements by
analyzing at least one of the sensors recorded angles or amplitudes
or frequency changes. Non-limiting examples of distance
measurements include: distance between the one or more electrodes
and the epicardial surface and distance between the one or more
electrodes and the one or more transducers and/or sensors.
The device can be configured to provide a tissue diagnostic through
an analysis of both tissue motion information and cell electrical
signals. The cell electrical signals can be recorded by the one or
more electrodes, while tissue motion information can be gathered by
the one or more electrodes and/or sensors. The device can be
configured to provide exact foci and conduction-gap position
information, such that ablation can be performed with an increased
level of precision. Small conduction paths, including "gaps" in a
line, are equally relevant as foci. The device can be used with an
ablation device, such as robotic or manually controlled catheter
ablation device. The device can also be used with a pacing system,
such as a system for delivering pacing electrodes into the heart
and for stimulating the heart with pacing pulses delivered through
the pacing electrodes.
In accordance with one aspect of the present disclosure, a device
generates a table of dipole densities .nu.(P',t) that embody an
ionic nature of cellular membranes across the epicardium of a given
heart of a patient. The device comprises: a measuring and recording
unit that measures and records electric potential data Ve at given
positions P proximate the patient's torso surface; an a/d-converter
that converts the electric potential data Ve into digital voltage
data; a processor that transforms the digital voltage data into
cellular membrane dipole density data; and a memory that stores the
electric potential data Ve and the transformed cellular membrane
dipole density data.
In some embodiments, the measuring and recording unit includes
multiple electrodes positioned proximate the patient's torso
surface. The device can further comprise a wearable garment, and
the multiple electrodes can be coupled to the wearable garment. The
wearable garment can be flexible and conform closely to the
patient's torso surface. The wearable garment can be configured to
urge the multiple electrodes against the torso surface with a
consistent position to prevent movement of at least one of the
multiple electrodes.
In various embodiments, the wearable garment can be selected from
the group consisting of: vest; shirt; bib; arm band; torso band;
any patient-attachable assembly capable of maintaining the one or
more electrodes in contact with the torso surface or sufficiently
close thereto that a monitorable signal is detectable; and/or
combinations thereof.
In some embodiments, the processor executes a computer program
embodying an algorithm for transforming the digital voltage data
into cellular membrane dipole density data. The computer program
can be stored in a storage device, e.g., an electrical, magnetic,
and/or optical storage device. The storage device can be a
non-transitory storage device.
In some embodiments, the device further comprises one or more
ultrasound transducers positioned proximate the patient's torso
surface, the one or more ultrasound transducers being configured to
emit waves toward an epicardial surface; and one or more ultrasound
sensors positioned proximate the patient's torso surface, the one
or more ultrasound sensors being configured to receive reflections
of the waves from the epicardial surface and produce sensor data.
The processor can be configured to receive the sensor data from the
one or more sensors and generate distance measurements from the
epicardial surface. The processor can be configured to produce the
distance measurements by analyzing at least one of: timing of
received signal; recorded signal amplitude; sensor recorded angle;
or signal frequency changes.
The device can further comprise at least one wearable garment, and
the at least one of the multiple electrodes, one or more ultrasound
transducers, or one or more ultrasound sensors can be coupled to
the at least one wearable garment. The at least one wearable
garment can comprise a first wearable garment and a second wearable
garment, and the multiple electrodes can be coupled to the first
wearable garment, and the one or more ultrasound transducers and
one or more ultrasound sensors can be coupled to the second
wearable garment. In various embodiments, the at least one wearable
garment can be selected from the group consisting of: vest; shirt;
bib; arm band; torso band; any patient-attachable assembly capable
of maintaining the one or more electrodes, one or more ultrasound
transducers, and/or one or more ultrasound sensors in contact with
the torso surface, or sufficiently close thereto that a monitorable
signal is detectable; and/or combinations thereof.
In some embodiments, the device can be configured to diagnose at
least one of: an arrhythmia; ischemia; or compromised myocardial
function.
In some embodiments, the device can be configured to treat at least
one of: an arrhythmia; ischemia; or compromised myocardial
function.
In accordance with another aspect of the present disclosure, a
device for creating a database of dipole densities d(y) at an
epicardial surface of the heart of a patient comprises: multiple
electrodes positioned proximate the patient's torso surface; a
first receiver configured to receive mapping information from the
multiple electrodes; a second receiver configured to receive an
anatomical depiction of the heart; a dipole density module
configured to generate the database of dipole densities d(y) of
polygonal shaped projections onto the epicardial surface, wherein
the dipole density module computes the dipole density at all
vertices of the polygonal shaped projections, wherein if the dipole
density is d(y), the total measured potential V(x) at a location x
is the sum over all vertices of d(y) times a matrix {acute over
(.omega.)}(x,y), and wherein: a) x represents a series of locations
on the torso surface; and b) V(x) is a measured potential at point
x, said measured potential recorded by the multiple electrodes.
In some embodiments, the dipole density module can generates the
database of dipole densities d(y) using a finite elements
method.
In some embodiments, the polygonal shaped projections can be
substantially the same size.
In some embodiments, the dipole density can be determined by a
number of polygonal shaped projections, wherein the number can be
determined by the size of the epicardial surface.
In some embodiments, the polygonal shaped projections can be
selected from the group consisting of: triangles; squares;
tetrahedral shapes; hexagonal shapes; any other suitable shape
compatible with finite elements method; and/or combinations
thereof.
In some embodiments, the device can further comprise a wearable
garment, and the multiple electrodes can be coupled to the wearable
garment. The wearable garment can be flexible and conform closely
to the patient's torso surface. The wearable garment can be
configured to urge the multiple electrodes against the torso
surface with a consistent position to prevent movement of the
electrodes. The wearable garment can be selected from the group
consisting of: vest; shirt; bib; arm band; torso band; any
patient-attachable assembly capable of maintaining the one or more
electrodes in contact with the torso surface or sufficiently close
thereto that a monitorable signal is detectable; and/or
combinations thereof.
In some embodiments, the anatomical depiction of the heart can
comprise previous anatomical imaging and/or real-time anatomical
imaging from one or more of CT; MRI; internal ultrasound; external
ultrasound; or other imaging apparatus.
In some embodiments, the anatomical depiction of the heart can
comprise a generic model of a heart.
In some embodiments, the device can further comprise: one or more
ultrasound transducers positioned proximate the patient's torso
surface, the one or more ultrasound transducers being configured to
emit waves toward the epicardial surface; and one or more
ultrasound sensors positioned proximate the patient's torso
surface, the one or more ultrasound sensors being configured to
receive reflections of the waves from the epicardial surface.
The device can further comprise at least one wearable garment, and
at least one of the multiple electrodes, one or more ultrasound
transducers, and/or one or more ultrasound sensors can be coupled
to the at least one wearable garment. The at least one wearable
garment can comprise a first wearable garment and a second wearable
garment, and the multiple electrodes can be coupled to the first
wearable garment, and the one or more ultrasound transducers and/or
one or more ultrasound sensors can be coupled to the second
wearable garment. The at least one wearable garment can be selected
from the group consisting of: vest; shirt; bib; arm band; torso
band; any patient-attachable assembly capable of maintaining the
one or more electrodes, one or more ultrasound transducers, and/or
one or more ultrasound sensors in contact with the torso surface,
or sufficiently close thereto that a monitorable signal is
detectable; and/or combinations thereof. The anatomical depiction
of the heart can comprise real-time anatomical imaging from the one
or more ultrasound transducers and the one or more ultrasound
sensors.
In some embodiments, the device can be configured to diagnose at
least one of: anarrhythmia; ischemia; or compromised myocardial
function.
In some embodiments, the device can be configured to treat at least
one of: an arrhythmia; ischemia; or compromised myocardial
function.
In accordance with another aspect of the present disclosure, a
method of creating a database of dipole densities d(y) at the
epicardial surface of the heart of a patient comprises: placing an
array of multiple electrodes proximate the patient's torso surface;
and calculating dipole densities d(y) by: receiving mapping
information from the multiple electrodes; receiving an anatomical
depiction of the heart; and generating the database of dipole
densities d(y) with a dipole density module, wherein the dipole
density module determines dipole densities d(y) of polygonal shaped
projections onto the epicardial surface, wherein the dipole density
module computes the dipole density at all vertices of the polygonal
shaped projections, wherein if the dipole density is d(y), the
total measured potential V(x) at a location x is the sum over all
vertices of d(y) times a matrix {acute over (.omega.)}(x,y), and
wherein: a) x represents a series of locations on the torso
surface; and b) V(x) is a measured potential at point x, said
measured potential recorded by the multiple electrodes.
In some embodiments, the dipole density module can generate the
database of dipole densities d(y) using a finite elements
method.
In some embodiments, the method can further comprise providing a
wearable garment, and the multiple electrodes can be coupled to the
wearable garment. The wearable garment can be configured to urge
the multiple electrodes against the torso surface with a consistent
position to prevent movement of the electrodes. The wearable
garment can be selected from the group consisting of: vest; shirt;
bib; arm band; torso band; any patient-attachable assembly capable
of maintaining the one or more electrodes in contact with the torso
surface or sufficiently close thereto that a monitorable signal is
detectable; and/or combinations thereof.
In some embodiments, the method can include using the dipole
densities d(y) to locate an origin of abnormal electrical activity
of a heart.
In some embodiments, the method can include using the dipole
densities d(y) to diagnose at least one of: an arrhythmia;
ischemia; or compromised myocardial function.
In some embodiments, the method can include using the dipole
densities d(y) to treat at least one of: an arrhythmia; ischemia;
or compromised myocardial function.
In some embodiments, calculating the dipole densities d(y) can
include a processor executing a computer program stored in a
memory, the computer program embodying an algorithm for generating
a table of dipole densities in the memory. The memory can be a
non-transitory storage device, such as an electrical, magnetic,
and/or optical storage device, as examples.
In accordance with another aspect of the present disclosure, a
device for creating a database of dipole densities d(y) and
distance measurements at an epicardial surface of a patient
comprises: an array of multiple electrodes positioned proximate the
patient's torso surface; one or more ultrasound transducers
positioned proximate the patient's torso surface, the one or more
ultrasound transducers being configured to emit waves toward the
epicardial surface; one or more ultrasound sensors positioned
proximate the patient's torso surface, the one or more ultrasound
sensors being configured to receive reflections of the waves from
the epicardial surface; and a computer coupled to the multiple
electrodes, one or more ultrasound transducers, and one or more
ultrasound sensors, wherein the computer is configured to receive
mapping information from the multiple electrodes and sensor data
from the one or more sensors, and generate the database of dipole
densities d(y) and distance measurements.
In some embodiments, the device can further comprise at least one
wearable garment, and at least one of the multiple electrodes, one
or more ultrasound transducers, and/or one or more ultrasound
sensors can be coupled to the at least one wearable garment. The
wearable garment can be flexible and conform closely to the body of
the patient. The wearable garment can be configured to urge
electrodes, sensors and/or transducers against the torso surface
with a consistent position to prevent movement of the electrodes,
sensors and/or transducers. The at least one wearable garment can
be selected from the group consisting of: vest; shirt; bib; arm
band; torso band; any patient-attachable assembly capable of
maintaining the one or more electrodes, one or more ultrasound
transducers, and one or more ultrasound sensors in contact with the
torso surface, or sufficiently close thereto that a monitorable
signal is detectable; and combinations thereof.
In various embodiments, the at least one wearable garment can
comprise a first wearable garment and a second wearable garment,
and the multiple electrodes can be coupled to the first wearable
garment, and the one or more ultrasound transducers and/or one or
more ultrasound sensors can be coupled to the second wearable
garment. The computer can be coupled to the wearable garment.
In some embodiments, the computer can include: a dipole density
module configured to generate a three dimensional database of
dipole densities d(y), and wherein the dipole density module
determines a dipole density for polygonal shaped projections onto
the epicardial surface and computes the dipole density at all
vertices of the polygonal shaped projections, wherein if the dipole
density is d(y), the total measured potential V(x) at a location x
is the sum over all vertices of d(y) times a matrix {acute over
(.omega.)}(x,y), and wherein: a) x represents a series of locations
on the torso surface; and b) V(x) is a measured potential at point
x, said measured potential recorded by the multiple electrodes. The
dipole density module can generate the database of dipole densities
d(y) using a finite elements method. The polygonal shaped
projections can be substantially the same size. The dipole density
can be determined by a number of polygonal shaped projections, the
number determined by the size of an epicardial surface. Such module
can include or be embodied in, as examples, hardware, computer
program code, firmware, and/or combinations thereof.
In some embodiments, the device can be configured to provide
epicardial surface motion information of the heart. The device can
be configured to provide tissue diagnostic information by analyzing
both motion information and cell electrical signals. The cell
electrical signals can be recorded by the multiple electrodes.
In some embodiments, the device can further include a display
configured to display real time motion.
In some embodiments, the computer can be configured to produce a
geometrical depiction of the heart.
In some embodiments, the device can be further configured to
determine properties of the cardiac wall. The properties can
include cardiac wall thickness information. The properties can
include precise foci, conduction-gaps, and/or conduction channels
position information.
In some embodiments, the distance measurement can comprise the
distance between at least one of the multiple electrodes and at
least one epicardial surface.
In some embodiments, the device can be configured to produce the
distance measurement by analyzing at least one of: timing of
received signal; recorded signal amplitude; sensor recorded angle;
or signal frequency changes.
In some embodiments, the device can be configured to provide
epicardial surface information during a cardiac ablation procedure.
The ablation procedure can comprise delivery of RF, ultrasound,
microwave, cryogenic and/or laser energy to tissue.
In some embodiments, at least one of the sensors and at least one
of the transducers can comprise a single component.
In some embodiments, at least one of the sensors and at least one
of the transducers can be integral to at least one electrode of the
multiple electrodes.
In some embodiments, the computer can be configured to determine a
map of dipole densities d(y) at corresponding time intervals.
In some embodiments, the computer can be configured to generate a
synthesis of maps that represents a cascade of activation sequences
of each corresponding heart beat from a series of heart beats.
In some embodiments, the device can be configured to diagnose at
least one of: an arrhythmia; ischemia; or compromised myocardial
function.
In some embodiments, the device can be configured to treat at least
one of: an arrhythmia; ischemia; or compromised myocardial
function.
In accordance with another aspect of the present disclosure, a
method of creating a database of dipole densities d(y) and distance
measurements at an epicardial surface of a patient comprises:
placing an array of multiple electrodes, one or more ultrasound
transducers, and one or more ultrasound sensors proximate the
patient's torso surface; and calculating dipole densities d(y) by:
receiving mapping information from the multiple electrodes;
emitting waves toward the epicardial surface with the one or more
ultrasound transducers; receiving reflections of the waves from the
epicardial surface with the one or more ultrasound sensors;
producing a geometrical depiction of the epicardial surface;
generating the database of dipole densities d(y) with a dipole
density module, wherein the dipole density module determines dipole
densities d(y) of polygonal shaped projections onto the epicardial
surface, wherein the dipole density module computes the dipole
density at all vertices of the polygonal shaped projections,
wherein if the dipole density is d(y), the total measured potential
V(x) at a location x is the sum over all vertices of d(y) times a
matrix {acute over (.omega.)}(x,y), and wherein: a) x represents a
series of locations on the torso surface; and b) V(x) is a measured
potential at point x, said measured potential recorded by the
multiple electrodes; and calculating distance or movement
information by analyzing signals received from the sensor.
In some embodiments, the dipole density module can be configured to
generate the database of dipole densities d(y) using a finite
elements method.
In some embodiments, the method can further comprise providing at
least one wearable garment, wherein at least one of the multiple
electrodes, one or more ultrasound transducers, and one or more
ultrasound sensors can be coupled to the at least one wearable
garment. The at least one wearable garment can be configured to
urge the electrodes, sensors and/or transducers against the torso
surface with a consistent position to prevent movement of the
electrodes, sensors and/or transducers. The at least one wearable
garment can be selected from the group consisting of: vest; shirt;
bib; arm band; torso band; any patient-attachable assembly capable
of maintaining the one or more electrodes in contact with the torso
surface or sufficiently close thereto that a monitorable signal is
detectable; and/or combinations thereof.
In various embodiments, the at least one wearable garment can
comprise a first wearable garment and a second wearable garment and
the multiple electrodes can be coupled to the first wearable
garment, and the one or more ultrasound transducers and one or more
ultrasound sensors can be coupled to the second wearable
garment.
In some embodiments, calculating distance information can comprise
calculating tissue thickness information.
In some embodiments, the method can include using the dipole
densities d(y) to locate an origin of abnormal electrical activity
of a heart.
In some embodiments, the method can include using the dipole
densities d(y) to diagnose at least one of: an arrhythmia;
ischemia; or compromised myocardial function.
In some embodiments, the method can include using the dipole
densities d(y) to treat at least one of: an arrhythmia; ischemia;
or compromised myocardial function.
In some embodiments, calculating the dipole densities d(y) can
include a processor executing a computer program stored in a
memory, the computer program embodying an algorithm for generating
a table of dipole densities in the memory.
In some embodiments, at least one ultrasound transducer can
comprise at least one ultrasound sensor.
In accordance with another aspect of the present disclosure, a
device for creating a database of dipole densities d(y) at the
epicardial surface and endocardial surface of the heart of a
patient comprises: an external array of multiple electrodes
positioned proximate the patient's torso surface; an internal array
of multiple electrodes positioned within a chamber of the heart; a
first receiver configured to receive mapping information from the
external and internal array of multiple electrodes; a second
receiver configured to receive an anatomical depiction of the
heart; a dipole density module configured to generate the database
of dipole densities d(y) of polygonal shaped projections onto the
epicardial surface and endocardial surface, wherein the dipole
density module computes the dipole density at all vertices of the
polygonal shaped projections, wherein if the dipole density is
d(y), the total measured potential V(x) at a location x is the sum
over all vertices of d(y) times a matrix {acute over
(.omega.)}(x,y), and wherein: a) x represents a series of locations
on the torso surface; and b) V(x) is a measured potential at point
x, said measured potential recorded by the multiple electrodes.
In some embodiments, the dipole density module can be configured to
generate the database of dipole densities d(y) using a finite
elements method.
In some embodiments, the polygonal shaped projections can be
substantially the same size.
In some embodiments, the dipole density can be determined by a
number of polygonal shaped projections, wherein the number can be
determined by the size of an epicardial surface and endocardial
surface.
In some embodiments, the device can further comprise a wearable
garment, and the external array of multiple electrodes can be
coupled to the wearable garment.
In some embodiments, the device can further comprise a catheter,
and the internal array of multiple electrodes can be coupled to the
catheter.
In some embodiments, the anatomical depiction of the heart can
comprise a generic model of a heart.
In some embodiments, the device can further comprise: one or more
external ultrasound transducers positioned proximate the patient's
torso surface, the one or more ultrasound transducers being
configured to emit waves toward the epicardial surface; and one or
more external ultrasound sensors positioned proximate the patient's
torso surface, the one or more ultrasound sensors being configured
to receive reflections of the waves from the epicardial
surface.
The device can further comprise at least one wearable garment, and
the at least one of the multiple external electrodes, one or more
external ultrasound transducers, or one or more external ultrasound
sensors can be coupled to at least one wearable garment. The
anatomical depiction of the epicardial surface of the heart can
comprise real-time anatomical imaging from the one or more external
ultrasound transducers and the one or more external ultrasound
sensors.
In some embodiments, the device can further comprise: one or more
internal ultrasound transducers positioned within a chamber of the
heart, the one or more ultrasound transducers being configured to
emit waves toward the endocardial surface; and one or more internal
ultrasound sensors positioned within a chamber of the heart, the
one or more ultrasound sensors being configured to receive
reflections of the waves from the endocardial surface. The at least
one of the multiple internal electrodes, one or more internal
ultrasound transducers, or one or more internal ultrasound sensors
can be coupled to a catheter. The anatomical depiction of the
endocardial surface of the heart can comprise real-time anatomical
imaging from the one or more internal ultrasound transducers and
the one or more internal ultrasound sensors.
In some embodiments, the device can be configured to diagnose at
least one of: an arrhythmia; ischemia; or compromised myocardial
function.
In some embodiments, the device can be configured to treat at least
one of: an arrhythmia; ischemia; or compromised myocardial
function.
In accordance with another aspect of the present disclosure, a
portable system for obtaining mapping information at an epicardial
surface of the heart of a patient comprises: a wearable garment
proximate the patient's torso; an array of multiple electrodes
coupled to the wearable garment proximate the patient's torso
surface; and a device configured to receive mapping information
from the multiple electrodes.
In some embodiments, the multiple electrodes can be wired and/or
wirelessly connected to the device.
In some embodiments, the device can include a recording device
configured to record the mapping information.
In some embodiments, the device can include a communication system
configured to transmit the mapping information to a remote
location.
In some embodiments, the device can include a computer configured
to receive the mapping information from the multiple electrodes and
generate a database of dipole densities d(y). The computer can be
further configured to transmit the mapping information and/or
dipole densities d(y) to a remote location.
In some embodiments, the device can be coupled to the wearable
garment.
In some embodiments, the portable system can further comprise: one
or more ultrasound transducers coupled to the wearable garment, the
one or more ultrasound transducers being configured to emit waves
toward the epicardial surface; and one or more ultrasound sensors
coupled to the wearable garment, the one or more ultrasound sensors
being configured to receive reflections of the waves from the
epicardial surface; wherein the portable system is configured to
receive information from the ultrasound sensors. The portable
system can include a recording device coupled to the one or more
ultrasound sensors and configured to receive and record sensor data
from the one or more ultrasound sensors. The portable system can
include a communication system coupled to the one or more
ultrasound transducers and one or more ultrasound sensors and
configured to transmit the sensor data from the one or more sensors
to a remote location. The portable system can include a computer
coupled to the one or more ultrasound transducers and one or more
ultrasound sensors, and the computer can be configured to receive
sensor data from the one or more sensors and to determine distance
measurements to the epicardial surface.
In some embodiments, the portable system can further comprise one
or more functional elements, the one or more functional elements
comprising one or more elements selected from the group consisting
of: a pressure sensor such as a blood pressure sensor; a pH sensor;
a glucose sensor; a respiration sensor; a salinity or other sweat
level sensor; an EEG sensor such as an EEG sensor placed on the
scalp of the patient; an oxygen level sensor such as an oxygen
level sensor placed on the finger of the patient; an eye gaze
sensor; and/or combinations of these. The one or more functional
elements can be coupled to the wearable garment. The portable
system can include a recording device operably coupled to the one
or more functional elements and configured to receive and record
data from the one or more functional elements. The portable system
can include a communication system operably coupled to the one or
more functional elements and configured to transmit data from the
one or more functional elements to a remote location. The portable
system can include a computer operably coupled to the one or more
functional elements, and the computer can be configured to receive
data from the one or more functional elements. The computer can
comprise one or more algorithms constructed and arranged, when
executed by at least one computer processor, to analyze one or more
of: cardiac geometry; cardiac electrical activity; blood pressure;
pH; glucose; respiration; sweat level; brain activity; and/or blood
oxygen level. The computer can be configured to analyze cardiac
electrical activity and at least one physiologic parameter selected
from the group consisting of: blood pressure; pH; glucose;
respiration; sweat level; brain activity; and/or blood oxygen
level.
In some embodiments, the system can be configured to diagnose at
least one of: an arrhythmia; ischemia; or compromised myocardial
function.
In some embodiments, the system can be configured to treat at least
one of: an arrhythmia; ischemia; or compromised myocardial
function.
In accordance with another aspect of the present disclosure, a
portable system for obtaining information at an epicardial surface
of the heart of a patient comprises: a wearable garment positioned
proximate the patient's torso surface having array of multiple
electrodes, one or more transducers, one or more sensors and/or one
or more functional elements coupled to the wearable garment; and a
portable device configured to receive information from the
electrodes, transducers, sensors and/or functional elements.
In some embodiments, the wearable garment can be selected from the
group consisting of: vest; shirt; bib; arm band; torso band; any
patient-attachable assembly capable of maintaining the one or more
electrodes, one or more ultrasound transducers, and/or one or more
ultrasound sensors in contact with the torso surface, or
sufficiently close thereto that a monitorable signal is detectable;
and/or combinations thereof.
In some embodiments, the functional elements can include an element
selected from the group consisting of: a pressure sensor such as a
blood pressure sensor; a pH sensor; a glucose sensor; a respiration
sensor; a salinity or other sweat level sensor; an EEG sensor such
as an EEG sensor placed on the scalp of the patient; an oxygen
level sensor such as an oxygen level sensor placed on the finger of
the patient; an eye gaze sensor; and/or combinations of these. The
portable system can include a computer, and the computer can
comprise one or more algorithms constructed and arranged to, when
executed by at least one computer processor, analyze one or more
of: cardiac geometry; cardiac electrical activity; blood pressure;
pH; glucose; respiration; sweat level; brain activity; and blood
oxygen level. The computer can be configured to analyze cardiac
electrical activity and at least one physiologic parameter selected
from the group consisting of: blood pressure; pH; glucose;
respiration; sweat level; brain activity; and/or blood oxygen
level.
In some embodiments, the wearable garment includes multiple
wearable garments, and the array of multiple electrodes, one or
more transducers, one or more sensors and/or one or more functional
elements can be coupled to one or more of the multiple wearable
garments.
In some embodiments, the portable system includes a computer
coupled to the multiple electrodes and the computer can include one
or more algorithms constructed and arranged to analyze mapping
information from the multiple electrodes and generate the database
of dipole densities d(y).
In some embodiments, the portable system includes a computer
coupled to the one or more ultrasound transducers and one or more
ultrasound sensors: the one or more ultrasound transducers being
configured to emit waves toward the epicardial surface; the one or
more ultrasound sensors being configured to receive reflections of
the waves from the epicardial surface; and wherein the computer
includes one or more algorithms constructed and arranged to receive
sensor data from the one or more sensors to determine distance
measurements to the epicardial surface.
In some embodiments, the system can be configured to diagnose at
least one of: an arrhythmia; ischemia; or compromised myocardial
function.
In some embodiments, the system can be configured to treat at least
one of: an arrhythmia; ischemia; or compromised myocardial
function.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates an exemplary embodiment of a mapping system, in
accordance with aspects of the present invention.
FIG. 2 illustrates a computer architecture forming part of the
mapping system of FIG. 1, in accordance with aspects of the present
invention.
FIG. 3 illustrates a schematic view for determining a database
table of dipole densities d(y), in accordance with aspects of the
present invention.
FIG. 4 illustrates a schematic view for determining a database
table of dipole densities d(y) using finite elements, in accordance
with aspects of the present invention.
FIG. 5 illustrates a flow chart of a method for determining a
database table of dipole densities, in accordance with aspects of
the present invention.
FIG. 6 is an example embodiment of a method of determining and
storing dipole densities, in accordance with aspects of the present
invention.
FIG. 7 illustrates a schematic view combining both external and
internal systems for determining dipole densities d(y) using finite
elements, in accordance with aspects of the present invention.
FIG. 8 illustrates an exemplary embodiment of a home usable mapping
system capable of recording or communicating with the physician, in
accordance with aspects of the present invention.
DETAILED DESCRIPTION
Various exemplary embodiments will be described more fully
hereinafter with reference to the accompanying drawings, in which
some exemplary embodiments are shown. The present inventive concept
can, however, be embodied in many different forms and should not be
construed as limited to the exemplary embodiments set forth
herein.
It will be understood that, although the terms first, second, etc.
are used herein to describe various elements, these elements should
not be limited by these terms. These terms are used to distinguish
one element from another, but not to imply a required sequence of
elements. For example, a first element can be termed a second
element, and, similarly, a second element can be termed a first
element, without departing from the scope of the present invention.
As used herein, the term "and/or" includes any and all combinations
of one or more of the associated listed items.
It will be understood that when an element is referred to as being
"on" or "attached", "connected" or "coupled" to another element, it
can be directly on or connected or coupled to the other element or
intervening elements can be present. In contrast, when an element
is referred to as being "directly on" or "directly connected" or
"directly coupled" to another element, there are no intervening
elements present. Other words used to describe the relationship
between elements should be interpreted in a like fashion (e.g.,
"between" versus "directly between," "adjacent" versus "directly
adjacent," etc.).
The terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting of
the invention. As used herein, the singular forms "a," "an" and
"the" are intended to include the plural forms as well, unless the
context clearly indicates otherwise. It will be further understood
that the terms "comprises," "comprising," "includes" and/or
"including," when used herein, specify the presence of stated
features, steps, operations, elements, and/or components, but do
not preclude the presence or addition of one or more other
features, steps, operations, elements, components, and/or groups
thereof.
Spatially relative terms, such as "beneath," "below," "lower,"
"above," "upper" and the like can be used to describe an element
and/or feature's relationship to another element(s) and/or
feature(s) as, for example, illustrated in the figures. It will be
understood that the spatially relative terms are intended to
encompass different orientations of the device in use and/or
operation in addition to the orientation depicted in the figures.
For example, if the device in the figures is turned over, elements
described as "below" and/or "beneath" other elements or features
would then be oriented "above" the other elements or features. The
device can be otherwise oriented (e.g., rotated 90 degrees or at
other orientations) and the spatially relative descriptors used
herein interpreted accordingly.
Various exemplary embodiments are described herein with reference
illustrations of idealized or representative structures and
intermediate structures. As such, variations from the shapes of the
illustrations as a result, for example, of manufacturing techniques
and/or tolerances, are to be expected. Thus, exemplary embodiments
should not be construed as limited to the particular shapes of
regions illustrated herein but are to include deviations in shapes
that result, for example, from manufacturing.
The catheters and other devices described in accordance with
aspects of the present invention can include numerous forms of
diagnostic catheters, such as catheters including one or more
electrodes, or therapeutic catheters such as tissue ablation
catheters. Catheters can be introduced percutaneously into a
patient's heart, such as to record electrical activity, measure
distances between structures, or deliver energy. External devices
and systems can be included, such as body surface electrodes used
to record electrical activity or deliver an electric signal, or
visualization devices such as external ultrasound or fluoroscopic
imaging systems. Any of these catheters or other devices can
include one or more electrodes and/or one or more ultrasound
elements (e.g. one or more ultrasound sensors and/or ultrasound
transducers). The electrodes and/or ultrasound elements of the
present invention can be positioned at any location on the device,
for example at a distal or proximal portion of the device, and can
be positioned internal or external to a patient's body.
Any or all of the ultrasound elements (e.g. ultrasound transducers
and/or ultrasound sensors) of the present invention can be used to
measure a distance between a sensor and/or a transducer and a
surface, as is known in the art. One example includes measuring the
distance between an ultrasound element comprising a
sensor-transducer pair and a wall of a chamber of the heart.
Any or all of the electrodes of the present invention can be used
to record electric "signals" (e.g. voltages and/or currents) at or
between one or more electrode locations. Recorded electric signals
can be used to map electrical activity of tissue. The mapped
electrical activity can be further processed (e.g. in terms of
sources of charge and charge density and correlated with various
physiologic parameters related to the function of the heart) and
the mapped electrical activity and other recorded and calculated
information can be provided visually to one or more operators of
the system of the present invention.
Any or all of the electrodes of the present invention can be used
to deliver and/or record electric signals that are generated by the
system. Such delivered signals can be emitted from any one or more
electrodes, and can be delivered between any two or more
electrodes. Recorded signals can comprise a signal present at a
single electrode location or at multiple electrode locations (e.g.
a signal representing a comparison of two or more signals present
at two or more electrode locations). Recorded signals can be
measured, for example, synchronously or asynchronously in terms of
voltage and/or current. Recorded signals can be further processed
in terms of, for example, resistive and reactive components of
impedance and/or the combined magnitude of impedance with any
original or processed signal "values" (e.g. those represented by a
parameter selected from the group consisting of: instantaneous
amplitude; phase; peak; Root-Mean-Square (rms); demodulated
magnitude; and combinations of these).
The terms "map" and "mapping" shall include, but need not be
limited to, "electrical map", "electrical mapping", "anatomical
map", "anatomical mapping", "device map" and "device mapping", each
of which is defined herein below.
The terms "electrical map" and "electrical mapping" shall include,
but need not be limited to, recording, processing and/or displaying
electrical information, such as electrical information recorded by
one or more electrodes described or understood in accordance with
the present invention. This electrical information includes, but is
not limited to: cardiac or other tissue voltage measurements;
cardiac or other tissue bipolar and/or unipolar electrograms;
cardiac or other tissue surface charge data; cardiac or other
tissue dipole density data; cardiac or other tissue monophasic
action potentials; and combinations of these.
The terms "anatomical map" and "anatomical mapping" shall include,
but need not be limited to, recording, processing and/or displaying
anatomical information, such as anatomical information provided by
one or more ultrasound elements of the present invention and/or one
or more electrodes described or understood in accordance with the
present invention. This anatomical information includes, but is not
limited to: two-dimensional (2D) or three-dimensional (3D)
representations of tissue, such as one or more chambers of a heart;
tissue wall thicknesses such as the thickness of an atrial or
ventricular wall; distance between two tissue surfaces; and
combinations of these. In some embodiments, a dipole density map
and/or surface charge map (hereinafter singly or collectively
dipole density map) is provided by using information provided by
multiple electrodes and multiple ultrasound elements, such as is
described in Applicant's co-pending international application,
Serial Number PCT/US2012/028593, entitled "Device and Method For
the Geometric Determination of Electrical Dipole Densities on the
Cardiac Wall", the entirety of which is incorporated herein.
The terms "device map" and "device mapping" shall include, but need
not be limited to, recording, processing and/or displaying of
device distance information, such as information comprising the
distance between a device or device component and another object,
such as tissue or another device or device component.
Any pair of electrodes described or understood in accordance with
the present invention can be constructed and arranged to provide
distance information, such as the distance between that pair of
electrodes, or the distance between one of the electrodes and one
or more proximate components (e.g. a component at a known distance
from one or both of the electrodes in the pair). By delivering and
recording an electric signal between electrodes of known separation
distances, the signal can by processed and/or calibrated according
to one or more known separation distances (e.g. the separation
distance between two electrodes fixedly mounted to a rigid
structure at a pre-determined distance). Calibrated signal values
can be combined across adjacent sets of electrode pairs to
accurately estimate the distance between any pair (e.g. any
arbitrary pair of electrodes on any one or more devices of the
system) of electrodes for which the separation distance is not
known. Known and calculated separation distances can be used as
"reference" electrodes and combined to triangulate the unknown
position of one or more "marker" electrodes, such as an electrode
positioned on the present invention or on a separate or external
device and positioned proximate the present invention. The process
of triangulation can be used to dynamically localize the
three-dimensional position of any or all of the electrodes either
individually and/or as a combined entity in three-dimensional
space.
Further, any or all electrodes described or understood in
accordance with the present invention, such as one or more
electrodes placed inside a chamber of a heart, can be used to
deliver electric energy, such as radiofrequency energy.
In accordance with aspects of the present invention, provided is an
improved device, system and method for calculating and visualizing
the distribution and activity of dipole densities and/or surface
charge (hereinafter singly or collectively dipole densities) on the
epicardial surface of the heart, and in some embodiments, dipole
densities on both the epicardial and endocardial surfaces
simultaneously. The dipole densities can be determined by a finite
elements method, avoiding the errors encountered using previous
extrapolation algorithms.
Calculating surface charge and/or dipole densities of the heart
with internal electrodes has been described in detail in U.S. Pat.
No. 8,417,313 (hereinafter the '313 patent), entitled "Method and
device for determining and presenting surface charge and dipole
densities on cardiac walls".
As discussed in the '313 patent, research indicated that the use of
the surface charge densities (i.e. their distribution) or dipole
densities (i.e. their distribution) to generate distribution map(s)
would lead to more detailed and precise information on electric
ionic activity of local cardiac cells than potentials. Surface
charge density or dipole densities represent precise information of
the electric activity with a compact spatial resolution, whereas
potentials resulting from integration of charge densities provide
only a diffuse picture of electric activity. The electric nature of
cardiac cell membranes comprising ionic charges of proteins and
soluble ions can be precisely described by surface charge and
dipole densities. The surface charge densities or dipole densities
cannot be directly measured in the heart, but instead must be
mathematically and accurately calculated starting from measured
potentials. In other words, the information of voltage maps
obtained by current mapping systems can be greatly refined when
calculating surface charge densities or dipole densities from
these.
The surface charge density means surface charge (Coulombs) per unit
area (cm.sup.2). A dipole, as such, is a neutral element, wherein a
part comprises a positive charge and the other part comprises the
same but negative charge. A dipole can better represent the
electric nature of cellular membranes, because in a biological
environment ion charges are not macroscopically separated.
A device for determining dipole densities on the heart wall with
internal electrodes has been described in detail in U.S. Patent
Publication No. US2010/0298690 (hereinafter the '690 publication)
and Patent Cooperation Treaty Publication No. WO2012/122517
(hereinafter the '517 publication), entitled "Device and method for
the geometric determination of electrical dipole densities on the
cardiac wall.
The '517 publication disclosed devices, systems, and methods for
determining the dipole densities on heart walls using one or more
catheters placed into the heart chamber. In particular, a
triangularization of the heart wall is performed in which the
dipole density at each vertex correlate to the potential measured
at various locations within the associated chamber of the heart. To
create a database of dipole densities, mapping information recorded
by one or more electrodes located on one or more catheters and
anatomical information is used. Additionally, one or more
ultrasound elements are provided on the catheter.
While the '313 patent, '690 publication and '517 publication
disclose devices, systems, and methods for creating an image of the
heart based on information recorded from one or more internal
electrodes (e.g. creating an anatomical and/or electrical
representation of the heart), some embodiments of the present
invention disclose devices, systems, and methods for creating a
heart image with external sensors (i.e. external sensors only),
while other embodiments disclose devices, systems, and methods
using both internal and external sensors to create the heart
image.
For imaging of the heart with external sensors, one or more
electrodes outside the body (external) can be positioned proximate
the surface of the patient's torso. In some embodiments, one or
more ultrasound elements (e.g. one or more ultrasound transducers,
sensors or combined transducer-sensors, hereinafter "ultrasound
element") can also be used with the one or more electrodes outside
the body, such as one or more ultrasound elements also positioned
proximate the surface of the patient's torso.
For the combination of signals from both external and internal
sensors to create an image of the heart, the external one or more
electrodes disclosed in the present invention are used with
internal (inside the body) electrodes disclosed in the internal
sensor-based devices, systems, and methods of the '313 patent, '690
publication and '517, combining heart chamber geometry with
internal and external sensor (voltage) readings, such that dipole
densities can be depicted as an animated color map of activation
for each heart beat across the epicardial and/or endocardium
surface. The information can be used to diagnose and/or treat a
patient with a cardiac arrhythmia, such as atrial fibrillation, or
an inadequately synchronized activation sequence, such as in heart
failure. Other information obtained can include precise location of
foci, conduction-gaps, and/or position of conduction channels.
In some embodiments of the present invention, a dipole density
library can be created in computer memory by combining the
electrode voltage readings from one or more electrodes proximate
the surface of the patient's torso with anatomical imaging from an
imaging instrument, such as CT; MRI; ultrasound; and/or a generic
model of a heart. This anatomical imaging can be generated in
real-time and/or imported from previous imaging from one or more of
CT, MRI, ultrasound (internal or external), or other imaging
apparatus.
In some embodiments of the present invention, the dipole density
library is created by combining the electrode voltage readings from
one or more electrodes with ultrasound readings recorded by the one
or more ultrasound elements proximate the surface of the patient's
torso. Alternatively or additionally, the dipole density library is
created by combining the electrode voltage readings from one or
more electrodes with ultrasound readings recorded by one or more
ultrasound elements positioned within the patient's body, such as
one or more ultrasound elements positioned within one or more
chambers of the patient's heart.
In some embodiments, the system of the present invention comprises
an external device, for example a vest, having one or more
electrodes, and optionally, one or more ultrasound elements. FIG. 1
shows an example embodiment of a mapping system 100 that can be
used for real time dipole density mapping of a heart 12 of a human
10. System 100 can include a computer 110 having known types of
input devices and output devices, such as a display 120 and printer
130, coupled to a patient attachment device, vest 140, having one
or more electrodes 142. In some embodiments, vest 140 can further
include one or more ultrasound elements 144. Ultrasound elements
144 can include one or more ultrasound transducers configured to
transmit ultrasound waves, such as sound waves configured to
reflect off of one or more structures of the heart, and be recorded
or otherwise received by one or more ultrasound sensors.
Alternatively or additionally, ultrasound elements 144 can include
one or more ultrasound sensors, such as one or more ultrasound
sensors which receive the reflected sound waves. In some
embodiments, one or more ultrasound elements 144 can include both
an ultrasound transmitter and an ultrasound sensor, such as a
single element that both transmits and receives ultrasound
waves.
While a vest is shown, numerous alternative patient attachment
device types can be used, including, for example, shirts, bibs, arm
bands, torso bands and/or any other patient-attachable assembly
capable of maintaining the one or more electrodes 142 and/or
ultrasound elements 144 in contact with the wearer's body, or
sufficiently close thereto, such that a signal can be detected
and/or transmitted by each signal-detecting element. Alternatively
or additionally, the one or more electrodes 142 and/or ultrasound
elements 144 can be attached directly to the skin. In some
embodiments, multiple discrete attachments can be used with a
combination of garments, (e.g. shirt plus armband or torso band
plus armband), or a combination of a garment with direct skin
attachment(s).
In some embodiments, vest 140 can only include one or more
electrodes 142, with no ultrasound elements. In other embodiments,
vest 140 can include one or more ultrasound elements 144, and not
have any electrodes. In still other embodiments a combination of
garments can be used with different elements being positioned on
different garments. For example, in a combination of shirt plus
armband, the shirt can have one or more electrodes 142 while the
armband can have one or more ultrasound elements 144.
In some embodiments, vest 140 is flexible and conforms closely to
the body of the patient and can be made of any suitable materials.
Vest 140 can be configured so that the one or more electrodes 142
and/or ultrasound elements 144 are urged against the skin at a
consistent position, such as to prevent movement of the element
across the skin. In some embodiments, the one or more electrodes
142 and/or ultrasound elements 144 can be positioned on both the
front and the back of the patient. In other embodiments, the one or
more electrodes 142 and/or ultrasound elements 144 can be
positioned only on the front or back of the patient, depending on
application.
The one or more electrodes 142 and/or ultrasound elements 144 can
be connected to computer 110, such as via a wired and/or wireless
connection (see FIG. 8). Computer 110 can control the operation of
the one or more electrodes 142 and/or ultrasound elements 144. In
some embodiments, computer 110 can shut off selected electrodes 142
and/or ultrasound elements 144, leaving only the associated
electrodes 142 and/or ultrasound elements 144 that cover one or
more areas of interest being turned on.
System 100 can be used to create a three-dimensional database of
dipole densities d(y) and distance measurements at the epicardial
surface of the heart. The distance measurements can include, but
are not limited to: the distance between at least one of the
electrodes 142 and the epicardial surface, the distance between at
least one of the electrodes 142 and an ultrasound element 144, and
the distance between the epicardial surface and an ultrasound
element 144. Knowing the speed of sound in the particular
environment, as well as the timing of the delivery of sound waves
by the transducer, the distance between an ultrasound transducer, a
reflected surface, and an ultrasound sensor can be calculated, as
described herein below. Alternatively or additionally, the distance
measurements can be calculated by analyzing the received signal
amplitude, a shift in frequency between transmitted and received
signals, and/or an ultrasound sensor recorded angle. System 100 can
also be configured to produce continuous, real time geometries of
the tissue of a patient. System 100 can provide one or more of:
tissue geometry information such as tissue position, tissue
thickness (e.g. cardiac wall thickness) and tissue motion (e.g.
cardiac wall motion) information; distance information such as
distance between two tissue locations, and distance between a
tissue location and a device component location; tissue electrical
activity information; status of ablation of a portion of tissue;
status of resynchronization pacing, and/or combinations of
these.
In some embodiments, the present invention incorporates one or more
ultrasound elements 144 comprising both an ultrasound transducer
and an ultrasound sensor, each preferably contained in a single
component. The ultrasound sensor is configured to record or
otherwise detect the wave reflections that result from the
ultrasound waves emitted from one or more ultrasound transducers.
In addition to determining real-time continuous anatomical geometry
information, the detected wave reflections can be used to determine
real-time continuous measurements of the position of at least one
of the electrodes 142 and/or at least one ultrasound element 144.
This information can be used to enhance one or more dipole density
d(y) calculations. Measurements can be taken to determine the
thickness of an object, such as the thickness of cardiac tissue,
which can be used to determine an ablation parameter such as power
or time of energy delivery.
In a typical embodiment, an ultrasound element 144 comprising a
piezo crystal transmits acoustic waves and receives the reflections
of those waves. As is well known to those skilled in the art, the
timing between transmitting and receiving can be used to determine
the distance between the transmitting and receiving surfaces, and
one or more reflective surfaces (e.g. reflective tissue surfaces).
In some embodiments, precise distances and dimensions of target
cardiac tissue is determined, resulting in a more precise and
effective diagnosis and/or therapy.
By having precise anatomical and other distance information, the
dipole density calculations will be similarly precise. In some
embodiments, one or more ultrasound elements 144 are constructed
and arranged to produce sound waves in at least one of either
constant or pulsed excitation, such as sounds waves between 3
megahertz and 18 megahertz. The waves emitted by one or more
ultrasound elements 144 can be at constant frequency and/or
produced by a chirp of changing frequency (to allow pulse
compression or demodulation on reception). The precision in dipole
density calculations along with the distance measurements will
allow for the precise detailing of the electrical activity in the
cardiac cells and will allow for the precise identification of
which cells are the earliest sites of activation. In some
embodiments, one or more ultrasound elements 144 can be configured
to automatically detect the distance from one or more ultrasound
elements 144 to the epicardial surface via a first reflection and
further detect the cardiac wall thickness via a second reflection.
In another embodiment, one or more ultrasound elements 144
integrate multiple reflections to construct an anatomical geometry
including an epicardial surface of the heart and the thickness of
the associated myocardium.
In some embodiments, one or more ultrasound elements 144 include at
least one crystal, typically comprised of a piezoelectric material,
which is positioned proximate to the center of each electrode 142
within an electrode array. In another embodiment, one or more
ultrasound elements 144 include at least one crystal positioned
between two or more electrodes 142, such as to create a device with
a ratio of mapping electrodes 142 to ultrasound elements 144 of
1:1, 2:1, 5:2, 3:1, 4:1 or another ratio. The at least one crystal
can be constructed and arranged to transmit ultrasonic signals
and/or to receive ultrasonic signals (e.g. receive ultrasonic
signals transmitted by the same or different crystals and/or the
reflections of those signals). In another embodiment, one or more
ultrasound elements 144 comprise a plurality of crystals, such as a
plurality of crystals arranged in an array.
In some embodiments, one or more ultrasound elements 144 comprise a
piezoelectric film covering one or more electrodes 142, such as one
or more electrodes 142 within an array. In some embodiments, one or
more ultrasound elements 144 can be constructed as part of an
electrode 142. For example, system 100 can comprise a
sensor/electrode combination.
FIG. 2 provides an example embodiment of a computer architecture
200 that can form part of mapping system 100. Architecture 200
includes interface module 210 for interfacing with the vest 140,
interface module 220 for interfacing with output devices 120, 130,
and at least one processor 240. The computer 110 includes at least
one computer memory 250. The foregoing are generally known, however
the present invention further includes an electric-potential to
surface-charge-density and/or dipole-density converter module 230.
Converter module 230 includes instructions necessary for carrying
out the methods described herein, when executed by processor 240,
wherein the results of such processing are stored in memory 250, as
would be understood by one skilled in the art having the benefit of
this disclosure.
In some embodiments, the 3D geometry can be accommodated by
integrating anatomical data from CT/MRI scans with the epicardial
geometry determined from analysis of the received acoustic signals.
The CT/MRI scans can include data to determine torso geometry. The
CT/MRI scans can also provide data associated with an epicardial
surface surrounding the heart, where those of ordinary skill would
understand that the epicardial surface can be used to register the
CT/MRI data with data calculated from the devices of the present
invention. Further, locating the epicardial surface can include
determining or otherwise providing data to be associated with the
location of the heart within the torso.
In accordance with some embodiments of the invention, system 100 is
configured to generate a table of dipole densities v(P', t) that
embody an ionic nature of cellular membranes across the epicardium
of a given heart of a patient, comprising:
a) a measuring and recording unit that measures and records
electric potential data V.sub.e at given positions P proximate the
patient's torso surface,
b) an a/d-converter that converts the at least one electric
potentials V.sub.e into digital voltage data,
c) a processor that transforms the digital voltage data into dipole
charge density data, and
d) a memory that stores the electric potential data V.sub.e and the
transformed cellular membrane dipole density data.
Referring again to FIG. 2, architecture 200 includes a measuring
and recording unit, such as interface module 210 which is
configured to obtain electric potential data V.sub.e at given
positions P proximate the patient's torso surface, the converter
module 230 includes an a/d-converter that converts the electric
potentials V.sub.e into digital voltage data, the processor 240
transforms the digital voltage data into dipole charge density
data, and the memory 250 stores the electric potential data V.sub.e
and the transformed cellular membrane dipole density data.
The measuring and recording unit includes multiple electrodes
positioned proximate the patient's torso surface. In some
embodiments, the system can further include a wearable garment and
at least one of the multiple electrodes can be coupled to the
wearable garment. In some embodiments, the wearable garment is
flexible and conforms closely to the patient's torso surface and
can urge one or more electrodes against the torso surface with a
consistent position to prevent movement of the one or more
electrodes. The wearable garment can be selected from the group
consisting of: vest; shirt; bib; arm band; torso band; any
patient-attachable assembly capable of maintaining the one or more
electrodes in contact with the torso surface or sufficiently close
thereto; and/or combinations thereof.
In some embodiments, the processor includes a computer program
embodying an algorithm that, when executed, transforms the digital
voltage data into cellular membrane dipole density data.
In some embodiments, the system further includes one or more
ultrasound transducers positioned proximate the patient's torso
surface, the one or more ultrasound transducers being configured to
emit waves toward an epicardial surface, and one or more ultrasound
sensors positioned proximate the patient's torso surface, the one
or more ultrasound sensors being configured to receive reflections
of the waves from the epicardial surface, wherein the measuring and
recording unit further measures and records the sensor information.
In some embodiments, one or more ultrasound transducers are further
configured to function as an ultrasound sensor.
In some embodiments, the processor is configured to receive sensor
data from the one or more sensors and generate distance
measurements from the epicardial surface. The distance measurement
can be produced by analyzing at least one of: timing of received
signal; recorded signal amplitude; sensor recorded angle; or signal
frequency changes
In some embodiments, the system includes more than one wearable
garment and the multiple electrodes, ultrasound transducers, or
ultrasound sensors are coupled to different wearable garments. For
example, the multiple electrodes are coupled to a first wearable
garment, and the ultrasound transducers and ultrasound sensors are
coupled to a second wearable garment. The wearable garments can be
selected from the group consisting of: vest; shirt; bib; arm band;
torso band; any patient-attachable assembly capable of maintaining
the one or more electrodes, one or more ultrasound transducers, and
one or more ultrasound sensors in contact with the torso surface,
or sufficiently close thereto that a monitorable signal is
detectable.
In some embodiments, the system further includes an imaging unit
that represents the cellular membrane dipole densities v(P',t) as a
two-dimensional image or time-dependent sequence of images.
In some embodiments, the system further includes an imaging unit
that represents the cellular membrane dipole densities v(P',t) as a
three-dimensional image or time-dependent sequence of images.
FIG. 3 shows a schematic view of some elements of computer 110 used
for determining a database table of dipole densities d(y). Computer
110 includes a first receiver 310 configured to receive electrical
potentials from the one or more electrodes, such as electrodes 142
of FIG. 1. Computer 110 further includes a second receiver 320
configured to receive cardiac geometry information from an imaging
instrument, such as CT; MRI; ultrasound; or a generic model of a
heart. This anatomical imaging can be generated in real-time and/or
imported from previous imaging from one or more of CT, MRI,
ultrasound (internal or external), or other imaging apparatus.
Dipole density processor 330 receives electrical information from
first receiver 310 and cardiac geometry information from the second
receiver 320. Dipole density processor 330, which can comprise
converter module 230 and processor 240, includes a mathematical
processing element or other electronic module including software
and/or hardware for performing mathematical or other calculations.
Dipole density processor 330 preferably uses one or more algorithms
to process the received electrical and geometry information to
produce a database table of dipole densities d(y) 350.
Alternatively or additionally, dipole density processor 330 can be
configured to produce a database table of surface charge
information.
As discussed above, in some embodiments the vest 140 can further
include one or more ultrasound transducers and/or one or more
ultrasound sensors to provide cardiac geometry information to the
second receiver 320. The one or more ultrasound transducers
transmit ultrasound waves, such as waves configured to reflect off
one or more structures of the heart, and be recorded by the
ultrasound sensors (e.g. reflections from the epicardial surface
and one or more of the inner surfaces or structures of the heart).
Dipole density processor 330 receives electrical information from
first receiver 310 and ultrasound cardiac geometry information from
the second receiver 320. Dipole density processor 330, which can
comprise converter module 230 and processor 240, includes a
mathematical processing element or other electronic module
including software and/or hardware for performing mathematical or
other calculations. Dipole density processor 330 preferably uses
one or more algorithms to process the received electrical and
geometry information to produce a database table of dipole
densities d(y) 350.
The geometric model of the epicardial surface can be processed by
the dipole density processor 330 into multiple small triangles
(triangularization) and/or other polygonal shapes (e.g., squares,
tetrahedral, hexagonal, and others). When the polygons are
sufficiently small, the dipole density has a small variation over
the polygon. In a preferred embodiment, the number of triangles is
determined by dipole density processor 330. With the electrodes
positioned by a clinician, such as an electrophysiologist, the
potentials at each electrode are recorded. The dipole density
processor 330 computes the dipole density at all vertices of the
triangles. If the dipole density at a vertex is d(y), the total
measured potential V(x) at a location x is the sum over all
vertices y of d(y) times a matrix W(x,y). A detailed description is
provided in reference to FIG. 4.
In a preferred embodiment, dipole density processor 330 implements
a progressive algorithm that can be modified and/or refined in
order to improve spatial and/or time resolution of the database of
dipole densities that are produced. The dipole densities d(y) can
be obtained by solving a linear system of equations. Thereby a map
of dipole densities can be created at each corresponding time
interval. The synthesis of the maps generates a cascade of the
activation sequence of each corresponding heart beat that can be
used to diagnose cardiac wall tissue, such as to identify an origin
of aberrant electrical activity or otherwise diagnose an
arrhythmia. These sequential activation maps of dipole densities
and/or other dipole density information as described herein can be
used to diagnose and/or treat numerous forms of cardiac disease
such as when the dipole density information is used to diagnose
and/or treat an arrhythmia, ischemia and/or compromised myocardial
function.
The measuring electrodes used in the present invention are placed
on or proximate the torso surface. Due to the inhomogeneous
structure of the body, it is difficult to localize the actual
sources of the skin electrode measured potentials. A highly
complicated boundary value problem must be solved with boundary
conditions that are poorly known. Prior art attempts at determining
the "action potential" from body surface ECG (alone) have not been
very successful.
Utilizing the formulas in the '313 patent, '690 publication and
'517 publication, the present invention calculates the dipole
densities using external electrodes on the vest, in combination
with cardiac geometry information from an imaging instrument (such
as CT; MRI; ultrasound); or the optional external ultrasound
transducers and/or ultrasound sensors on the vest.
Referring now to FIG. 4, an embodiment of a system for determining
a database table of dipole densities d(y) of a patient is
illustrated. System 100, shown in FIG. 1, is configured to create a
database table of three-dimensional dipole densities d(y) based on
voltage potentials and image information relating to the heart, as
has been described above.
As shown in FIG. 4, triangle T1, defined by system 100 is at
location Y1. The contribution of triangle T1 to the potential at
location X1 can be computed from the dipole density at the vertices
of T1. The dipole density processor 330 determines the desired
dipole density d(y) from the total measured potential V(x), which
is the sum resulting from all the triangles defined by system
100.
When sufficient potential values V(x) are measured (e.g. from 10 to
10,000 with increasing number of measured potentials providing more
accurate results), the dipole density d(y) at many equally
distributed vertices y on the epicardial surface is calculated
(e.g. from 10 to 50,000 with increasing number of calculated
potentials providing more detailed results) by solving a system of
linear equations. By interpolation of the measured and/or
calculated potentials (e.g. with application of splines) their
number can be increased to a higher number of regions. This
calculation of dipole density results, such as via an automatic
computer program forming at least part of dipole density processor
330.
In some embodiments, the results are presented in a visual,
anatomical format, such as depicting the dipole densities on a
geometric model of the epicardial surface in relation to time (t).
This format allows a clinician, such as an electrophysiologist, to
determine the activation sequence, or other electrical and
mechanical measures, on the epicardial surface, such as to
determine treatment locations for a cardiac arrhythmia or other
inadequacy in cardiac tissue health, such as force of tissue
contraction and motion of the epicardial surface. The results can
be shown on a display unit 120, or on a separate display not shown,
such as a color display. In some embodiments, the device of the
present invention is implemented as, or includes, a software
program that is executable by at least one processor. The software
program can be integrated into one or more of: an ECG system; a
cardiac tissue ablation system; an imaging system; a computer; and
combinations of these.
FIG. 5 illustrates one embodiment of a method for determining a
database table of dipole densities d(y) of the epicardial surface
of a patient's heart. In Step 10, a vest having an array of one or
more electrodes (e.g. vest 140 of system 100 of FIG. 1) is placed
on the torso of the patient. In Step 20, the geometry of the
epicardial surface can be obtained in relation to the positions of
the one or more electrodes disposed within the electrode array. In
addition to the epicardial surface geometry, the magnitude and
other properties of motion of cardiac wall tissue can be
determined. In addition, the thickness of a patient's heart tissue
can be determined. This information will enable a clinician to
determine what treatment, (e.g., what ablation parameters) can be
appropriate for the patient. One or more ultrasound transducers and
sensors can be utilized in this step, as discussed above.
Alternatively or additionally, the geometry of the epicardial
surface is obtained in relation to the electrode array position,
such as by importing a geometry model from an imaging study (e.g.,
using computed tomography, MRI and/or ultrasound). The surface of
the geometry of the corresponding epicardial surface is generally
divided into small polygons, such as in the form of at least 1000
triangles of similar size.
In Step 30, the dipole density d(y) can be calculated at each
vertex y from the measured potential values x. The measurements can
be repeated successively during the cardiac cycle, such as once
each millisecond, giving the electrophysiologist a dynamic
progression of the activation sequence. The information of the time
dependent dipole densities can be depicted as an animated color map
of activation for each heart beat across the epicardial surface.
The information can be used to diagnose and/or treat a patient with
a cardiac arrhythmia, such as atrial fibrillation, or an
inadequately synchronized activation sequence, such as in heart
failure. Other information obtained can include precise location of
foci, conduction-gaps, and/or position of conduction channels.
The dipole density information can be used to determine cardiac
tissue treatment locations for lesion creation, such as a lesion
created by a catheter-based ablation system. Alternatively, the
lesion can be created by an RF, ultrasound, microwave, laser and/or
cryogenic energy ablation catheter. The information can also be
used to determine the location of pacing electrodes for cardiac
resynchronization therapy.
In some embodiments, ablating the cardiac tissue can be based upon
the tissue diagnosis. For example, the anatomical information
comprising tissue thickness information and at least one of the
magnitude of ablation energy or the time period in which ablation
energy is delivered, is adjusted based on the tissue thickness
information recorded by one or more ultrasound sensors.
FIG. 6 summarizes one method 400 for determining and storing
surface charge densities and/or dipole densities in accordance with
aspects of the present invention, which have been described in
detail above.
In Step 402, mapping system 100 is used to measure and/or calculate
one or more electric potential(s) V.sub.e in one or more
position(s) P at a given time t. In Step 404, V.sub.e is
transformed into a surface charge density .rho.(P',t) and/or dipole
density d(P',t) In Step 406, the surface charge density .rho.(P',t)
and/or dipole density d(P',t) is stored in a database table. The
method is repeated if there is another P, in Step 408.
FIG. 7 shows an embodiment using both external sensor systems and
internal sensor systems together. For example, the present systems
and methods disclosed above for external sensor-based imaging of
the heart can be combined with the devices, systems, and methods
using internal sensor-based imaging of the heart disclosed in the
'313 patent, '690 publication and '517 publication. FIG. 7 shows
the present vest system in combination with system 500, described
in detail in the '690 publication and '517 publication, each of
which is hereby incorporated by reference. This combination of
internal and external electrodes can be used to augment accuracy,
specificity, etc., and combining heart chamber geometry with
internal and external sensor (voltage) readings can provide
simultaneous maps of the epicardium and endocardium walls.
System 500 includes a mapping catheter with a shaft 311, which is
inserted into a chamber of a patient's heart, such as the Left
Atrium (LA). At the distal end of shaft 311 is an electrode array
315 including multiple electrodes 316. Electrode array 315 is shown
in a basket construction, but numerous other constructions can be
used including multiple independent arms, spiral arrays, electrode
covered balloons, and other constructions configured to place
multiple electrodes into a three-dimensional space. Any catheter
with one or more electrodes can be used to supply mapping
information to system 100, which is configured to create a database
table of three-dimensional dipole densities d(y) based on voltage
potentials and image information relating to the heart, as has been
described above.
As shown in FIG. 7, triangle T2, is at location Y2 on the
endocardial surface and electrode 316a is at location X2. The
contribution of triangle T2 to the potential at location X2 can be
computed from the dipole density at the vertices of T1. The dipole
density processor 330 determines the desired dipole density d(y)
from the total measured potential V(x), which is the sum resulting
from all the triangles defined by system 100.
When sufficient potential values V(x) are measured (e.g. from 10 to
50,000) with increasing number of measured potentials providing
more accurate results, the dipole density d(y) at many equally
distributed vertices y on the endocardial surface can be calculated
(e.g. from 10 to 50,000 with increasing number of calculated
potentials providing more detailed results) by solving a system of
linear equations. By interpolation of the measured and/or
calculated potentials (e.g. with application of splines) their
number can be increased to a higher number of regions.
In some embodiments, the results are presented in a visual,
anatomical format, such as on a display depicting the dipole
densities on a geometric model of the endocardial surface and
epicardial surface in relation to time (t). This format allows a
clinician, such as an electrophysiologist, to determine the
activation sequence, or other electrical and mechanical measures,
on the endocardial surface and/or epicardial surface, such as to
determine treatment locations for a cardiac arrhythmia or other
inadequacy in cardiac tissue health, such as force of tissue
contraction and motion of an endocardial surface and/or an
epicardial surface. The results can be shown on a display unit 120,
or on a separate display not shown, such as a color display.
FIG. 8 shows embodiments for a mapping system 600 for monitoring of
a patient at their home or otherwise remote from a clinical
setting. The system 600 can use many of the elements and methods
described above for determination of dipole densities. The system
600 includes a vest 640, which can use the same or similar features
as vest 140 described above, and a recording device 604a, computer
604b and/or communication system 604c.
Vest 640 can include one or more electrodes 642. In some
embodiments, vest 640 can further include one or more ultrasound
elements 644, such as one or more ultrasound transducers and/or
ultrasound sensors. Vest 640 can be flexible and conform closely to
the body of the patient and can be made of any suitable materials.
Vest 640 can be configured so that the one or more electrodes 642
and/or ultrasound elements 644 are urged against the torso surface
or skin at a consistent position, such as to prevent movement of
the element across the skin. In some embodiments, the one or more
electrodes 642 and/or ultrasound elements 644 can be positioned on
both the front and the back of the patient. In other embodiments,
the one or more electrodes 642 and/or ultrasound elements 644 can
be positioned on only the front or back of the patient, depending
on application. Alternatively, the one or more electrodes 642
and/or ultrasound elements 644 can be attached directly to the
skin. While the description discloses one or more electrodes 642
and/or one or more ultrasound elements 644 used with the vest,
garment, or direct skin attachment, the invention also envisions
embodiments that only include electrodes 642 or only ultrasound
elements 644.
In some embodiments, vest 640 or another component of system 600
includes one or more additional sensors or transducers, functional
element 645. Functional elements 645 can comprise an element
selected from the group consisting of: a pressure sensor such as a
blood pressure sensor; a pH sensor; a glucose sensor; a respiration
sensor; a salinity or other sweat level sensor; an EEG sensor such
as an EEG sensor placed on the scalp of the patient; an oxygen
level sensor such as an oxygen level sensor placed on the finger of
the patient; an eye gaze sensor; and combinations of these.
The one or more electrodes 642, ultrasound elements 644, and/or
functional elements 645 can be coupled to the recording device
604a, computer 604b and/or communication system 604c, with either a
wired (not shown) or wireless connection (e.g., Bluetooth, Wi-Fi,
or other wireless means). The recording device 604a, computer 604b
and/or communication system 604c can control the operation of the
one or more electrodes 642, ultrasound elements 644, and/or
functional elements 645. This control feature can be programmed
into their systems or can be done remotely via a remote connection
(e.g., from a physician's office 608). In some embodiments, the
recording device 604a, computer 604b and/or communication system
604c can turn on or shut off selected electrodes 642, ultrasound
elements 644, and/or functional elements 645, leaving only the
associated electrodes 642, ultrasound elements 644, and/or
functional elements 645 that cover one or more areas of interest
being turned on.
In some embodiments, the recording device 604a can be a portable
device for monitoring and recording various electrical and/or other
signal activities of the one or more electrodes 642, ultrasound
elements 644, and/or functional elements 645, similar to a Holter
or other mobile-patient monitor. The recording device 604a can be
configured to continuously monitor and record, or only record on an
as needed basis when a recordable event happens. Once the data is
recorded, the recording device 604a can be transmitted to the
physician's office to be analyzed. In other embodiments, the
recording device 604a can be a smart phone, such as a Galaxy S4,
having an application for recording the signal activities. Once
recorded, the smart phone can also be capable of transmitting the
information, for example, to the physician's office.
In some embodiments, the computer 604b can have the capability of
continuously monitoring various signal activities of the one or
more electrodes 642, ultrasound elements 644, and/or functional
elements 645. The computer 604b can also have the capability of
analyzing the data from the one or more electrodes 642, ultrasound
elements 644, and/or functional elements 645, similar to system 100
described above. In some embodiments, computer 604b comprises one
or more algorithms constructed and arranged to analyze one or more
of: cardiac geometry; cardiac electrical activity; blood pressure;
pH; glucose; respiration; sweat level; brain activity; or blood
oxygen level. In some embodiments, computer 604b analyzes cardiac
electrical activity and at least one physiologic parameter selected
from the group consisting of: blood pressure; pH; glucose;
respiration; sweat level; brain activity; or blood oxygen level.
The computer 604b can save the monitored or analyzed data in
memory, such as on memory card or flash device card or copy it to a
disk. The computer 604b can further have the capability of
transmitting the analyzed data, for example, to the physician's
office, giving the physician real-time feedback as to the health
and condition of their patient.
In some embodiments, communication system 604c can include a means
of communicating with the physician's office on a real-time basis
for remote medical patient monitoring, such as over the internet or
other direct communication means (e.g., smart phone). In this way,
the physician can monitor the patient 24 hours a day and/or at any
time. The system can further include two way communications such
that the physician can view the data in real-time while speaking
with the patient. The physician can also turn on or shut off
selected electrodes 642, ultrasound elements 644 and/or functional
elements 645, leaving only the associated electrodes 642,
ultrasound elements 644 and/or functional elements 645 that cover
one or more areas of interest being turned on.
Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the embodiments disclosed herein. It is intended that
the specification and examples be considered as exemplary only,
with a true scope and spirit of the invention being indicated by
the following claims. In addition, where this application has
listed the steps of a method or procedure in a specific order, it
can be possible, or even expedient in certain circumstances, to
change the order in which some steps are performed, and it is
intended that the particular steps of the method or procedure
claims set forth herein below not be construed as being
order-specific unless such order specificity is expressly stated in
the claim.
* * * * *
References